FLORMAR REBORN DOUBLE RADIANCE PRIMER HIGHLIGHTER SUNSCREEN BROAD SPECTRUM SPF 10- octinoxate cream 
Kosan Kozmetik Sanayi ve Ticaret A.S.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

flormar REBORN DOUBLE RADIANCE PRIMER HIGHLIGHTER SUNSCREEN BROAD SPECTRUM SPF 10

flormar REBORN DOUBLE RADIANCE PRIMER HIGHLIGHTER SUNSCREEN BROAD SPECTRUM SPF 10


Active ingredient

Octinoxate 5%

Purpose

Sunscreen

Uses

Warnings

Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.
For external use only

Do not use

on damaged or broken skin

When using this product

keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if

rash occurs

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Other information

Inactive ingredients

water, cyclopentasiloxane, isododecane, mica, butylene glycol, dimethicone, PEG-10 dimethicone, trimethylsiloxysilicate, polymethylsilsesquioxane, glycerin, phenoxyethanol, polysilicone-11, disteardimonium hectorite, cetyl PEG/PPG-10/1 dimethicone, hexyl laurate, polyglyceryl-4 isostearate, sodium chloride, triethoxycaprylylsilane, propylene carbonate, ethylhexylglycerin, algae extract, disodium EDTA, fragrance, laureth-12, chlorphenesin, propylene glycol, tea (Camellia sinensis) leaf extract, maté (Ilex paraguariensis) leaf extract, guarana (Paullinia cupana) seed extract, sodium dexydroacetate, titanium dioxide, iron oxides.

flormar REBORN DOUBLE RADIANCE PRIMER HIGHLIGHTER SUNSCREEN BROAD SPECTRUM SPF 10 30ml (61722-023-00)

Highlighter Inner Label 1Highlighter Inner Label 2

Highlighter Outer Label

FLORMAR REBORN DOUBLE RADIANCE PRIMER HIGHLIGHTER SUNSCREEN BROAD SPECTRUM SPF 10 
octinoxate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61722-023
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE50 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
ISODODECANE (UNII: A8289P68Y2)  
MICA (UNII: V8A1AW0880)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
GLYCERIN (UNII: PDC6A3C0OX)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
HEXYL LAURATE (UNII: 4CG9F9W01Q)  
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
LAURETH-12 (UNII: OAH19558U1)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)  
PAULLINIA CUPANA SEED (UNII: C21GE7524R)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61722-023-001 in 1 BOX06/16/2014
130 mL in 1 JAR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35206/16/2014
Labeler - Kosan Kozmetik Sanayi ve Ticaret A.S. (644090409)

Revised: 10/2019
Document Id: 952edeb0-6833-fe74-e053-2a95a90a8fbd
Set id: 8c5a456c-7cb9-46aa-bf42-66383a75f3a7
Version: 4
Effective Time: 20191018
 
Kosan Kozmetik Sanayi ve Ticaret A.S.